Insulin Assay Standardization

Leading to measures of insulin sensitivity and secretion for practical clinical care

  1. Myrlene A. Staten, MD1,
  2. Michael P. Stern, MD2,
  3. W. Greg Miller, PHD3,
  4. Michael W. Steffes, MD, PHD4,
  5. Scott E. Campbell, PHD5 and
  6. for the Insulin Standardization Workgroup
  1. 1National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland;
  2. 2Division of Clinical Epidemiology, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas;
  3. 3Department of Pathology, Virginia Commonwealth University, Richmond, Virginia;
  4. 4Department of Laboratory Medicine and Pathology, Medical School, University of Minnesota, Minneapolis, Minnesota;
  5. 5American Diabetes Association, Alexandria, Virginia.
  1. Corresponding author: Myrlene A. Staten, statenm{at}

Diabetes, primarily type 2 diabetes, has increased in prevalence throughout the world and current projections suggest a continued rise worldwide for at least the next quarter century. Insulin resistance, which frequently accompanies obesity, is known to be a key factor in the pathogenic development of type 2 diabetes (16). Type 2 diabetes occurs when insulin secretion is no longer sufficient to compensate for the resistance to the actions of insulin.

Measurements of insulin sensitivity and secretion are currently done only for research purposes and are only comparable in individual studies. There are no clinical applications for these measures. In fact, there are no criteria by which an individual could be classified as being insulin sensitive or resistant or as having mild, moderate, or severe impairment of insulin secretion. In theory, one could envision that knowledge of an individual's response to insulin or the ability to secrete insulin might be useful for selecting patients for intensified prevention efforts, in the choice of initial therapy upon onset of overt hyperglycemia, or in evaluating the response to therapy beyond glycemia. For example, if a person newly diagnosed with diabetes could be determined to be very insulin resistant, the choice of initial therapy could be a drug that primarily improves insulin sensitivity. On the other hand, if the person was only moderately insulin resistant but had more of a defect in insulin secretion, a drug that improves insulin secretion might …

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